(50 days)
The Tango+ is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, and percentage of oxygen saturation in arterial blood (SpO2) in adult patients during stress tests.
The SunTech Medical Tango+ Pulse Oximeter and NIBP monitor is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult patients in hospitals, medical facilities, and subacute environments.
1 11e Tango+, a microprocessor based ambulatory blood pressure monitor and oxygen saturation measurement system intended to be used with stress-test sytems, uses Korotkoff sounds to determine blood pressure and an optical finger sensor for oxygen saturation. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. Tango+ has the ability to make blood pressure at predetermined intervals (normally from a schedule determined by the physician), or on demand. Saturation measurements are updated once per second.
The provided 510(k) submission document for the SunTech Medical Inc. Tango + System largely focuses on demonstrating substantial equivalence to predicate devices and adherence to electrical safety and electromagnetic compatibility standards, with less detail on the specific clinical study design and results for establishing acceptance criteria for device performance.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that the SpO2 system was validated in a clinical test but does not provide specific numerical acceptance criteria for either blood pressure or oxygen saturation, nor does it present the quantitative results of these clinical tests. It only broadly states that the device "will have passed" several non-clinical tests and that the SpO2 system was "thoroughly tested" and "validated in a clinical test."
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Blood Pressure | Not Specified (Implied adherence to ANSI/AAMI SP10) | Not explicitly reported in the provided text. |
| Oxygen Saturation (SpO2) | Not Specified | Stated as "thoroughly tested" and "validated in a clinical test." No quantitative results provided. |
| Electrical Safety | EN 60601-1 | Stated to have passed. |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2 | Stated to have passed. |
| Biocompatibility | Not Specified | Stated that components "have had biocompatibility tests." |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The SpO2 system was validated in a clinical test." However, it does not provide any information regarding:
- The sample size used for this clinical test.
- The country of origin of the data.
- Whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document for either the blood pressure or SpO2 validation.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's standalone performance and its equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the information provided strongly suggests that a standalone performance evaluation was conducted, particularly for the SpO2 system. The statement "The SpO2 system was validated in a clinical test" implies evaluating the device's inherent measurement capabilities. For blood pressure, the direct reference to ANSI/AAMI SP10 suggests a standalone performance evaluation against the requirements of that standard.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for either blood pressure or SpO2 measurements in the validation studies.
- For blood pressure, given the common practice for non-invasive blood pressure devices, the ground truth would typically be invasive arterial pressure measurements or auscultation by trained observers (double auscultation with a mercury sphygmomanometer) as per standards like ANSI/AAMI SP10.
- For SpO2, the ground truth for validation studies usually involves co-oximetry (arterial blood gas analysis) to directly measure fractional oxygen saturation in arterial blood, often under controlled desaturation conditions.
8. The Sample Size for the Training Set
The document does not provide any information on a training set or its sample size. This is typical for a 510(k) submission unless the device involves complex machine learning algorithms that require explicit training and validation sets. The Tango+ System appears to be based on established physiological measurement principles (Korotkoff sounds for BP, optical finger sensor for SpO2) rather than a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, this information is not applicable/not provided.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).